The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Desoxyn (methamphetamine hydrochloride tablets, USP)

Prescribing Information

Medication Guide

BOXED WARNING

WARNINGS

• Serious Cardiovascular Events
  • Sudden Death and Pre-existing Structural Cardiac Abnormalities or other Serious Heart Problems
    • Children and Adolescents
    • Adults
    • Hypertension and other Cardiovascular Conditions
    • Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications
• Psychiatric Adverse Events
  • Pre-existing Psychosis
  • Biopolar Illness
  • Emergence of New Psychotic or Manic Symptoms
  • Agression
• Long-Term Suppression of Growth
• Seizures
• Visual Disturbance

PRECAUTIONS

• Information for Patients
  • Medication Guide
• Usage in Nursing Mothers
  • Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

MEDICATION GUIDE (new)

BOXED WARNING

...Misuse of methamphetamine may cause sudden death and serious cardiovascular adverse events.

WARNINGS

The following five subsections have been added:

• Sudden Death and Pre-existing Structural Cardiac Abnormalities or other Serious Heart Problems
• Psychiatric Adverse Events
• Long-Term Suppression of Growth
• Seizures
• Visual Disturbance

See highlighted prescribing information for new text..

Tindamax (tinidazole) Tablets for Oral Use

Prescribing Information (in new labeling format)

BOXED WARNING

• Warning: Potential Risk for Carcinogenicity

CONTRAINDICATIONS

WARNINGS & PRECAUTIONS

• Vaginal Candidiasis
• Drug Resistance

ADVERSE REACTIONS

• Bacterial Vaginosis
• Postmarketing Experience

DRUG INTERACTIONS

• Potential Effects of Other Drugs on Tinidazole
  • CYP3A4 Inducers and Inhibitors

USE IN SPECIFIC POPULATIONS

• Pregnancy
  • Teratogenic Effects: Pregnancy Category C
• Pediatric Use
  • Pediatric Administration
• Renal Impairment
• Hepatic Impairment

BOXED WARNING: Warning/Potential Risk for Carcinogenicity

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects...

CONTRAINDICATIONS

The use of tinidazole is contraindicated:

• In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome...
• In nursing mothers: Interruption of breast-feeding is recommended during tinidazole therapy and for 3 days following the last dose...

WARNINGS & PRECAUTIONS: Vaginal Candidiasis

The use of tinidazole may result in Candida vaginitis. In a clinical study of 235 women who received tinidazole for bacterial vaginosis, a vaginal fungal infection developed in 11 (4.7%) of all study subjects...

WARNINGS & PRECAUTIONS: Drug Resistance

Prescribing Tindamax in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets

Prescribing Information

Patient Package Insert

BOXED WARNING

WARNINGS

• Patients Coinfected with HIV and Hepatitis B Virus
• Renal Impairment
• Other

PRECAUTIONS

• Drug Interactions
  • Tenofovir Disoproxil Fumarate
• Bone Effects
  • Cases of osteomalacia...
• Information for Patients

ADVERSE REACTIONS

• Clinical Trials
  • Study 934 - Treatment Emergent Adverse Events
• Postmarketing Experience
  • Viread
    • Skin and Subcutaneous Tissue Disorders
• Rash
• Musculoskeletal and Connective Tissue Disorders
  • Myopathy
  • Osteomalacia...
• Renal and Urinary Disorders
  • Interstitial Nephritis (including acute cases)
• General Disorders and Administration Site Conditions
  • Asthenia

PATIENT PACKAGE INSERT

• What is the most important information I should know about Truvada?
• Who should not take Truvada?
• What should I tell my healthcare provider before taking Truvada?
• What should I avoid while taking Truvada?
• What are the possible side effects of Truvada?

BOXED WARNING

...Truvada is not approved for the treament of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread, the components of Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

WARNINGS: Patients Coinfected with HIV and Hepatitis B Virus

See highlighted labeling for revised text.

WARNINGS: Renal Impairment

Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of Viread.

It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Truvada. Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients at risk for renal impairment...

WARNINGS: Other

Truvada is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. Truvada should not be coadministered with Atripla, Emitriva, or Viread. Due to similarities between emtricitabine and lamivudine, Truvada should not be coadministered with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

Viread (tenofovir disoproxil fumarate) Tablets

Prescribing Information

Patient Package Insert

BOXED WARNING

WARNINGS

• Patients Coinfected with HIV and Hepatitis B Virus
• Renal Impairment
• Other

PRECAUTIONS

• Drug Interactions
• Bone Effects
  • Cases of osteomalacia...

ADVERSE REACTIONS

• Postmarketing Experience
  • Skin and Subcutaneous Tissue Disorders
    • Rash
  • Musculoskeletal and Connective Tissue Disorders
    • Myopathy
    • Osteomalcia...
  • Renal and Urinary Disorders
    • Interstitial Nephritis (including acute cases)
  • General Disorders and Administration Site Conditions
    • Asthenia

PATIENT PACKAGE INSERT

• Who should not take Viread?
• What should I tell my healthcare provider before taking Viread?
• What are the possible side effects of Viread?

BOXED WARNING

...Viread is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV and have discontinued Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV and HBV and discontinue Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

WARNINGS: Patients Coinfected with HIV and Hepatitis B Virus

See highlighted prescribing information for revised text.

WARNINGS: Renal Impairment

Tenofovir is principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of Viread...

It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with Viread. Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients at risk for renal impairment...

WARNINGS: Other

Viread should not be used in combination with the fixed-dose combination products Truvada or Atripla since it is a component of these products.

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Lovenox (enoxaparin sodium injection) for Subcutaneous and Intravenous Use 

Prescribing Information (in new labeling format)

CONTRAINDICATIONS

WARNINGS & PRECAUTIONS

• Percutaneous Coronary Revascularization Procedures

ADVERSE REACTIONS

• Clinical Trials Experience
  • Adverse Reactions in Lovenox-Treated Patients with Acute ST-Segment Elevation Myocardial Infarction

USE IN SPECIFIC POPULATIONS

• Geriatric Use
  • Prevention of DVT in hip, knee and abdominal surgery; treatment of DVT, Prevention of ischemic complications of unstable angina and non-Q-Wave myocardial infarction
    • Lovenox should be used with care in geriatric patients who may show delayed elimination of enoxaprin.
  • Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI)
• Hepatic Impairment

CONTRAINDICATIONS

...Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactoid reactions)...

WARNINGS & PRECAUTIONS: Percutaneous Coronary Revascularization Procedures

To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, non-Q-wave myocardial infarction and acute ST-segment elevation myocardial infarction, adhere precisely to the intervals recommended between Lovenox doses. It is important to achieve hemostasis at the puncture site after PCI. In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC Lovenox. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation.

Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use

Prescribing Information (in new labeling format)

CONTRAINDICATIONS

• Acute Critical Illness
• Prader-Willi Syndrome in Children
• Hypersensitivity

WARNINGS & PRECAUTIONS

• Acute Critical Illness
• Neoplasms
• Fluid Retention
• Progression of Preexisting Scoliosis in Pediatric Patients

ADVERSE REACTIONS

• Clinical Trials Experience
  • Clinical Trials in Children with Noonan Syndrome
• Postmarketing Surveillance
  • ...It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GHD itself, or other associated treatments such as radiation therapy...
  • The following additional adverse reactions...
    • Headaches (children & adults)
    • Gynecomastia (children)
    • Pancreatitis (children)

CONTRAINDICATIONS: Acute Critical Illness

Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness...

CONTRAINDICATIONS: Prader-Willi Syndrome in Children

Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment...

CONTRAINDICATIONS: Hypersensitivity

...Localized reactions are the most common hypersensitivity reactions...

WARNINGS & PRECAUTIONS: Acute Critical Illness

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin...

WARNINGS & PRECAUTIONS: Neoplasms

...Patients should be monitored carefully for potential malignant transformation of skin lesions, i.e. increased growth of preexisting nevi.

WARNINGS & PRECAUTIONS: Fluid Retention

Fluid retention during somatropin replacement therapy in adults may frequently occur...

WARNINGS & PRECAUTIONS: Progression of Preexisting Scoliosis in Pediatric Patients

...Skeletal abnormalities including scoliosis are commonly seen in untreated patients with Turner syndrome and Noonan syndrome...

Rocephin (ceftriaxone sodium) for Injection

Prescribing Information

See MedWatch Safety Alert posted 7/5/07 regarding Rocephin (ceftriaxone sodium) for Injection and recent labeling changes.

CONTRAINDICATIONS

WARNINGS

ADVERSE REACTIONS

• Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in both term and premature neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed.

CONTRAINDICATIONS

Hyperbilirubinemic neonates, especially prematures, should not be treated with
Rocephin. In vitro studies have shown that ceftriaxone can displace bilirubin from its
binding to serum albumin and bilirubin encephalopathy can possibly develop in these
patients.

Rocephin should not be administered concurrently with calcium-containing solutions or products in newborns because of the risk of precipitation of ceftriaxone-calcium salt (see WARNINGS).

WARNINGS

Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines.

Calcium-containing solutions or products must not be administered within 48 hours of last administration of ceftriaxone.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in both term and premature neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed (see CONTRAINDICATIONS and ADVERSE REACTIONS).

Brand (Generic) Name

Summary of Changes to Contraindications and Warnings

Aptivus (tipranvir) Capsules

Prescribing Information

WARNINGS

• Effects on Platelet Aggregation and Coagulation

WARNINGS: Effects on Platelet Aggregation and Coagulation

Aptivus/ritonavir should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other medical conditions, or who are receiving medications known to increase the risk of bleeding such as antiplatelet agents and anticoagulants, or who are taking supplemental high doses of vitamin E.

In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving Aptivus/Ritonavir.

In rats, co-administration with vitamin E increased the bleeding effects of tipranavir (see ANIMAL PHARMACOLOGY AND TOXICOLOGY).

Avelox (moxifloxacin hydrochloride) Tablets

Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection)

Prescribing Information

Patient Package Insert

WARNINGS

• Hypersensitivity Reactions
• Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...The risk of serious tendon disorders with quinolones is higher in those over 65 years of age, especially those on corticosteroids.
  • ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• Geriatric Use
  • ...The clinical trial data demonstrate that the safety of intravenous moxifloxacin in patients aged 65 or older was similar to that of comparator-treated patients.
  • ... In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Therefore, Avelox should be avoided in patients taking drugs that can result in prolongation of the QT interval (e.g. class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia).
  • ...Tendon rupture usually involves the Achilles, hand or shoulder tendons and can occur during therapy or up to a few months post completion of therapy...
• Postmarketing Adverse Event Reports
  • Hepatic Failure, including fatal cases
  • Toxic Epidermal Necrolysis

PATIENT PACKAGE INSERT

• What are possible side effects of Avelox?

WARNINGS: Hypersensitivity Reactions

...Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including Avelox. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following...

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted...

WARNINGS: Clostridium difficile associated diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Avelox, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

ChloraPrep (2% chlorhexidine gluconate (w/v) topical solution) 3-mL applicator with tint applicator containing FD&C Green #3 dye

Contact Enturia Inc. at 1-800-523-0502 for prescribing information.

WARNINGS

• Solution contains alcohol and gives off flammable vapors

WARNINGS

As stated in column 2.

Doxil (doxorubicin HCl liposome injection)

Prescribing Information (in new labeling format)

WARNINGS & PRECAUTIONS

• Cardiac Toxicity

ADVERSE REACTIONS

• Overall Adverse Reactions Profile
  • Cardiac Toxicity
  • Infusion Reactions
  • Myelosuppression
  • Hand-Foot Syndrome
• Adverse Reactions in Clnical Trials
  • Initial Paragraph
  • Patients With Multiple Myeloma
    • Table 10
  • Postmarketing Experience
• Use in Specific Populations
  • Geriatric Use

WARNINGS & PRECAUTIONS: Cardiac Toxicity

In the randomized multiple myeloma study, the incidence of heart failure events (ventricular dysfunction, cardiac failure, right ventricular failure, congestive cardiac failure, chronic cardiac failure, acute pulmonary edema and pulmonary edema) was similar in the Doxil + bortezomib group and the bortezomib monotherapy group, 3% in each group. LVEF decrease was defined as an absolute decrease of ≥15% over baseline or a ≥5% decrease below the institutional lower limit of normal. Based on this definition, 25 patients in the bortezomib arm (8%) and 42 patients in the Doxil + bortezomib arm (13%) experienced a reduction in LVEF.

Factive (gemifloxacin mesylate) Tablets

Prescribing Information

Patient Package Insert

WARNINGS

• QT Effects
• Hypersensitivity Reactions
  • Initial Paragraph
    • Fever
    • The drug should be discontinued immediately...
• Clostridium difficile associated Diarrhea (CDAD)

PRECAUTIONS

• Rash
  • Table 2
• Information for Patients
  • ...Rash occurs more commonly in those under 40, especially women and in women on hormone replacement therapy. The incidence of rash increases with duration more than 5 days and particularly longer than 7 days.
  • ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible
  • ...other central nervous system problems such as tremors, restlessness, lightheadedness, confusion and hallucinations may occur rarely
• Geriatric Use

ADVERSE REACTIONS

• Initial Section
• Adverse Events with a Frequency of Less than 1%
• Table 3
• Laboratory Changes
• Postmarketing Adverse Reactions

PATIENT PACKAGE INSERT

• What are possible side effects of Factive?
• What are the ingredients in Factive?

WARNINGS: QT Effects

...No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Factive treatment in over 8119 patients, including 707 patients concurrently receiving drugs known to prolong the QTc interval and 7 patients with hypokalemia...

WARNINGS: Hypersensitivity Reactions

Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including Factive. Hypersensitivity reactions reported in patients receiving fluroquinolone therapy have occasionally been fatal...

...Clinical manifestations may include one or more of the following: fever [added to list]

...The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted...

WARNINGS: Clostridium difficile associated Diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Factive, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Floxin Tablets (ofloxacin tablets)

Prescribing Information

WARNINGS

• Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

WARNINGS: Clostridium difficile associated diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Floxin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Prescribing Information

WARNINGS

• Thrombocytopenia

PRECAUTIONS

• Drug/Laboratory Test Interactions
  • Elevations of Serum Transaminases

ADVERSE REACTIONS

• Postmarketing Experience

WARNINGS: Thrombocytopenia

In Fragmin clinical trials supporting non-cancer indications, platelet counts of < 100,000/mm³ and < 50,000/mm³ occurred in < 1% and < 1% of patients, respectively.

In the clinical trial of patients with cancer and acute symptomatic venous thromboembolism treated for up to 6 months in the Fragmin treatment arm, platelet counts of < 100,000/mm³ occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm³. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the Fragmin arm and 8.1% of patients in the OAC arm...

Geodon (ziprasidone HCl) Capsules

Geodon (ziprasidone mesylate) for Injection for IM Use Only

Prescribing Information

WARNINGS

• QT Prolongation and Risk of Sudden Death

ADVERSE REACTIONS

• Other Events Observed During Postmarketing Use
  • Reproductive System and Breast Disorders
    • Priapism
  • Nervous System Disorders
    • Mania/Hypomania
    • Serotonin Syndrome (alone or in combination with serotonergic medicinal products)
    • Syncope
  • Skin and Subcutaneous Tissue Disorders
    • Allergic Reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria)

WARNINGS: QT Prolongation and Risk of Sudden Death

...Although torsade de pointes has not been observed in association with the use of ziprasidone at recommended doses in premarketing studies and experience is too limited to rule out an increased risk, there have been rare post-marketing reports (in the presence of multiple confounding factors)...

Haldol Decanoate (haloperidol) for IM Injection Only

Prescribing Information

WARNINGS

• Cardiovascular Effects

ADVERSE REATIONS

• Cardiovascular Effects
  • Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients...
  • Cases of sudden and unexpected death have been reported in association with the administration of Haldol...

WARNINGS: Cardiovascular Effects

Cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, including Haldol Decanoate.

Since QT-prolongation has been observed during Haldol Decanoate treatment, it is advised to be cautious in patients with QT-prolonging conditions (long QT-syndromes, hypokalaemia, electrolyte imbalance, drugs known to prolong QT, cardiovascular diseases, family history of QT prolongation). HALDOL DECANOATE MUST NOT BE ADMINISTERED INTRAVENOUSLY.

Haldol (haloperidol) Injection for Immediate Release

Prescribing Information

WARNINGS

• Cardiovascular Effects

ADVERSE REATIONS

• Cardiovascular Effects
  • Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients...
  • Cases of sudden and unexpected death have been reported in association with the administration of Haldol...

WARNINGS: Cardiovascular Effects

Cases of sudden death have been reported in psychiatric patients receiving antipsychotic drugs, including Haldol.

Since QT-prolongation has been observed during Haldol treatment, it is advised to be cautious in patients with QT-prolonging conditions (long QT-syndromes, hypokalaemia, electrolyte imbalance, drugs known to prolong QT, cardiovascular diseases, family history of QT prolongation). HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION.

Levaquin (levofloxacin) Tablets and Oral Solution

Levaquin (levofloxacin) Injection

Levaquin (levofloxacin in 5% dextrose) Injection

Prescribing Information

Patient Package Insert

WARNINGS

• Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS

• Postmarketing Adverse Reactions

PATIENT PACKAGE INSERT

• What are the possible side effects of Levaquin?

WARNINGS: Clostridium difficile associated diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Levaquin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

NegGram Caplets (nalidixic acid, USP)

Prescribing Information

WARNINGS

• Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

WARNINGS: Clostridium difficile associated diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including NegGram, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Norvir (ritonavir capsules) Soft Gelatin (ritonavir oral solution)

Prescribing Information

WARNINGS

• Drug Interactions
  • Tipranavir

PRECAUTIONS

• Drug Interactions
  • Table 6
    • HIV Protease Inhibitor
      • Atazanavir
      • Darunavir
      • Fosamprenavir
      • Saquinavir
      • Tipranavir

WARNINGS: Drug Interactions

Tipranavir co-administered with 200 mg of ritonavir has been associated with reports of clinical hepatitis and hepatic decompensation including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity.

PegIntron (peginterferon alfa-2b) Powder for Injection

Prescribing Information

Medication Guide: PegIntron (for use with PedIntron Powder for Injection)

Medication Guide: PegIntron Redipen Single-dose Delivery System

WARNINGS

• Neuropsychiatric Events

ADVERSE REACTIONS

• Postmarketing Experience
  • Pure Red Cell Aplasia

MEDICATION GUIDE

• What is the most important information I should know about PegIntron and PegIntron/Rebetol combination therapy?

WARNINGS: Neuropsychiatric Events

Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during Peglntron treatment and follow-up...

Plavix (clopidogrel bisulfate tablets)

Prescribing Information

WARNINGS

• Thrombotic Thrombocytopenic Purpura (TTP)

PRECAUTIONS

• Information for Patients
  • Patients should be told that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they take Plavix or Plavix combined with aspirin, and that they should report any unusual bleeding to their physician. Patients should inform physicians and dentists that they are taking Plavix and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken.

WARNINGS: Thrombotic Thrombocytopenic Purpura (TTP)

TTP has been reported rarely following use of Plavix, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever.

Rapamune (sirolimus) Oral Solution and Tablets

Prescribing Information

WARNINGS

• Exfoliative Dermatitis (term added)

PRECAUTIONS

• Renal Function
  • ...In patients with delayed graft function, Rapamune may delay recovery of renal function.
• Proteinuria
  • ...The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant population has not been established.

ADVERSE REACTIONS

• Other Clinical Experience
  • Exfoliative Dermatitis
  • Nephrotic Syndrome
  • ...In patients with delayed graft function, Rapamune may delay recovery of renal function.

WARNINGS

Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis, have been associated with the administration of sirolimus...

Tygacil (tigecycline) for Injection

Prescribing Information

WARNINGS

• Clostridium difficile associated diarrhea (CDAD)

PRECAUTIONS

• Information for Patients
  • ...Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

WARNINGS: Clostridium difficile associated diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Tygacil, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Anzemet Injection (dolasetron mesylate injection)

Prescribing Information

PRECAUTIONS

• Pediatric Use
  • Dolasetron should be administered with caution in pediatric patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. Rare cases of sustained supraventricular and ventricular arrhythmias, cardiac arrest leading to death, and myocardial infarction have been reported in children and adolescents...

Anzemet Tablets (dolasetron mesylate)

Prescribing Information

PRECAUTIONS

• Pediatric Use
  • Dolasetron should be administered with caution in pediatric patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. Rare cases of sustained supraventricular and ventricular arrhythmias, cardiac arrest leading to death, and myocardial infarction have been reported in children and adolescents...

BenzaClin Topical Gel (clindamycin - benzoyl peroxide gel)

Prescribing Information

PRECAUTIONS

• Carcinogenesis, Mutagenesis, Impairment of Fertility
  • In a 2-year dermal carcinogenicity study in rats, treatment with BenzaClin Topical Gel at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats. The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g BenzaClin Topical Gel, based on mg/m2) was statistically significantly higher than that in the sham- and vehicle-controls.

Concerta (methylphenidate HCl) Extended-Release Tablets

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Dexedrine (dextroamphetamine sulfate) Spansule Sustained-Release Capsules and Tablets

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules

Prescribing Information

Medication Guide

PRECAUTIONS

• Information for Patients
  • Medication Guide

MEDICATION GUIDE (new)

MS Contin (morphine sulfate controlled-release) Tablets

Prescribing Information

PRECAUTIONS

• General
  • Initial Sentence
  • Morphine may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings
• Use in Pancreatic/Biliary Tract Disorders
• Tolerance
• Physical Dependence
• Pregnancy: Teratogenic Effects: Category C
  • MS Contin should be used in pregnant women only if the need for strong opioid analgesia clearly outweighs the potential risk to the fetus...
• Neonatal Withdrawal Syndrome

ADVERSE REACTIONS

• Less Frequently Observed Reactions
  • Gastrointestinal
    • Dyspepsia
  • Genitourinary
    • Amenorrhea
  • Other
    • Bronchospasm

Ortho Tri-Cyclen Tablets

Ortho-Cyclen Tablets

(norgestimate/ethinyl estradiol)

Prescribing Information

PRECAUTIONS

• Pediatric Use
  • ...There was no significant difference between Ortho Tri-Cyclen Tablets and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density between baseline and Cycle 13 in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year treatment duration clinical trial for the Intent To Treat (ITT) population...

Prescribing Information

PRECAUTIONS

• Drug Interactions
  • Prevacid
    • ...Prevacid substantially decreases the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance...
    • ...It is theoretically possible that Prevacid may also interfere with the absorption of other drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, digoxin).

ADVERSE REACTIONS

• Postmarketing
  • Musculoskeletal System
    • Myositis
  • Urogenital System
    • Interstitial Nephritis

Primacor (milrinone lactate injection)

Primacor Flexible Containers (200 mcg/mL in 5% Dextrose Injection)

Prescribing Information

PRECAUTIONS

• General
  • There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. Cases of infusion site reaction have been reported with intravenous milrinone therapy. Consequently, careful monitoring of the infusion site should be maintained to avoid possible extravasation.

ADVERSE REACTIONS

• Postmarketing Adverse Event Reports
  • Isolated spontaneous reports of Bronchospasm and Anaphylactic Shock
  • Liver Function Test Abnormalities
  • Skin Reactions such as Rash
  • Administration Site Conditions
    • Infusion Site Reaction

Verelan PM (verapamil hydrochloride) Extended-Release Capsules Controlled Onset

Contact Elan Drug Delivery, Inc. at 1-888-638-7605 for prescribing information.

PRECAUTIONS

• Drug-Drug Interactions
  • Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class of antibiotics.
  
  

Dyazide (hydrochlorothiazide/triamterene) Capsules

Contact GlaxoSmithKline at 1-888-825-5249 for prescribing information.

ADVERSE REACTIONS

• Hypersensitivity
  • Subacute Cutaneous Lupus Erythematosus-like Reactions
• Metabolic
  • Hypokalemia
  • Hyponatremia
  • Acidosis
  • Hypercalcemia

Intron A (interferon alfa-2b, recombinant) for Injection

Prescribing Information

ADVERSE REACTIONS

• Postmarketing Experience

Prevacid I.V. (lansoprazole) for Injection

Prescribing Information

ADVERSE REACTIONS

• Postmarketing
  • Musculoskeletal System
    • Myositis
  • Urogenital System
    • Interstitial Nephritis

Levemir FlexPen (insulin detemir [rDNA origin] injection) in a 3 mL Prefilled Syringe

Patient Package Insert

PATIENT PACKAGE INSERT

• What is Levemir?

Levemir (insulin detemir [rDNA origin] injection) 3 mL PenFill Disposable Cartridge

Patient Package Insert

PATIENT PACKAGE INSERT

• What is Levemir?

Naprelan (naproxen sodium) Controlled Release Tablets

NSAID Medication Guide

Contact Stat-Trade, Inc. at 1-888-301-9680 for Medication Guide.

NSAID MEDICATION GUIDE

• Table: NSAID medicines that need a prescription
  • Vicoprofen
• Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. (included as footer)

FDA/CDER/Office of Drug Safety
Web page last revised by jlw August 01, 2007